Patient enrolment for Alzheimer's trial close to completion

Wednesday, 15 August, 2018

Patient enrolment for Alzheimer's trial close to completion

Biotechnology company Actinogen Medical has announced 75% enrolment in its Phase II clinical trial of Xanamem, its drug candidate for the treatment of mild Alzheimer’s disease.

Actinogen last month announced the addition of five new study sites in the US; these new sites have already contributed to the trial, with a significant cohort of potential new patients screened and a number enrolled into the study. In total, 131 of the 174 patients have been enrolled, meaning that only 43 patients remain to be enrolled for trial completion.

Actinogen has also partnered with dementia app developer MindMate to identify potential eligible patients. MindMate’s health and lifestyle app is used by over 1 million people worldwide who suffer from Alzheimer’s disease, dementia, brain injury and other forms of cognitive decline.

The new study sites in the US and partnership with MindMate, along with a number of other initiatives, have helped enhance and accelerate the patient recruitment process. The company remains on track to enrol the final patient by the end of this calendar year and expects to report the top-line trial data in the second quarter of 2019 — less than 12 months from now.

Actinogen Medical CEO Dr Bill Ketelbey said the board is impressed with the progress made with patient recruitment across the study sites in the USA, Australia and the UK.

“The US has by far the largest potential patient population, and the addition of the new study sites in this region has provided positive impetus to patient recruitment,” Dr Ketelbey said. “We’re exceptionally pleased with the progress and look forward to completing enrolment later this year. This will move us one step closer to providing the top-line trial results in less than 12 months.”

The company separately announced that one of its Clinical Advisory Board members, Professor Jeffrey Cummings, was awarded a Lifetime Achievement Award from the US Alzheimer’s Association at the recent Alzheimer’s Association International Conference (AAIC) in Chicago. The award is presented to individuals who have made a significant scientific contribution and lifetime commitment to the fight against Alzheimer’s disease and dementia.

Professor Cummings is a founding member of Actinogen’s Clinical Advisory Board and continues to provide invaluable advice and research expertise to the company in the development for Xanamem. He brings a wealth of knowledge and expertise to the field of brain health and clinical research, having founded the Cleveland Clinic Lou Ruvo Centre for Brain Health in Las Vegas and Cleveland. He is the Principal Investigator and Director of the NIH/NIGMS-funded Centre for Neurodegeneration and Translational Neuroscience, and the founding director of the UCLA Alzheimer’s Disease Research Centre.

“Having one of our advisory board members receive such a prestigious award reflects the exceptional calibre of internationally recognised academic experts supporting Actinogen’s development of Xanamem,” Dr Ketelbey said. “Jeff is a renowned Alzheimer’s researcher and has devoted much of his life to researching and developing treatments to fight against this devastating disease. No-one deserves this award more than Jeff and we’re delighted to have his intellect and research expertise to advise on the development of Xanamem.”

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